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Recall Observatory FDA recall evidence

Drug product

medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Single-Dose Vial, 150 mg/mL, Rx only, Manufactured for: Northstart Rx LLC, Memphis, TN, 38141, Manufactured by: Sun Pharmaceutical Industries Ltd., Halol Baroda Highway, Halol-389 350, Gujarat India , NDC 16714-981-01.

D-1146-2022

May 06, 2022

Class II

Product summary

Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Event
Event 90151
Status
Terminated
Classification
Class II
Quantity
180813 syringes
Official record key
drug-enforcement:D-1146-2022

Official wording

Reason: Lack of assurance of sterility

Code information: Lot: HAC2075A, Exp 06/2023; HAC2076A, Exp 07/2023; HAC2077A, HAC2078A, Exp 08/2023; HAC3803A, Exp 09/2023; HAC0551A, Exp 02/2023; HAC0562A, HAC1183A, Exp 03/2023; HAC1807A, Exp 06/2023; JKX6017A, JKX6018A Exp 12/2022; HAC0163A, Exp 01/2023; HAC1184A, Exp 04/2023; HAC0162A, Exp 12/2022.

Distribution pattern: USA Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of assurance of sterility